Container for surgical absorbent articles

ABSTRACT

A surgical container has more than one surgical sponge, more than one dispensing containers containing respectively the more than one surgical sponge, and more than one disposal containers each proximate to and visually associated respectively with the more than one dispensing containers to receive a used surgical sponge, wherein a selected surgical sponge is visible in one of the dispensing container or the corresponding disposal container.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. Nonprovisional applicationSer. No. 14/636,748, entitled “CONTAINER FOR SURGICAL ABSORBENTARTICLES” filed Mar. 3, 2015, which claims priority or the benefit ofU.S. Provisional Application 61/947,137, filed Mar. 15, 2014, thecontents of which are fully incorporated herein by reference.

BACKGROUND OF THE INVENTION 1. Field of the Invention

The field of art disclosed herein pertains to surgical containers forabsorbent articles such as sponges or gauzes, and more particularly tosurgical containers for tracking disposition of unused and usedabsorbent articles.

2. Description of the Related Art

Surgical procedures require use of absorbent articles such as spongesand gauze in order to collect bodily fluids. Maintaining sterileconditions for unused absorbent articles is one consideration. Anotherrequirement is that used absorbent articles be properly disposed of tomitigate biohazards. Another consideration is that all used absorbentarticles should be accounted for before finishing the surgicalprocedure. Leaving used absorbent articles in a body cavity of a patientmay cause serious risks to health as well as unacceptable consequencesto those responsible.

SUMMARY OF THE INVENTION

In one aspect, the present disclosure provides a surgical container thathas more than one surgical sponge, more than one dispensing containerscontaining respectively the more than one surgical sponge, and more thanone disposal containers each proximate to and visually associatedrespectively with the more than one dispensing containers to receive aused surgical sponge, wherein a selected surgical sponge is visible inone of the dispensing container or the corresponding disposal container.

These and other features are explained more fully in the embodimentsillustrated below. It should be understood that in general the featuresof one embodiment also may be used in combination with features ofanother embodiment and that the embodiments are not intended to limitthe scope of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

The various exemplary embodiments of the present invention, which willbecome more apparent as the description proceeds, are described in thefollowing detailed description in conjunction with the accompanyingdrawings, in which:

FIG. 1 illustrates an isometric view of a first example container fordispensing unused absorbent articles and for visibly disposing of usedabsorbent articles, according to one embodiment.

FIG. 2 illustrates an isometric view of a portion of a second examplecontainer for dispensing unused absorbent articles and for visiblydisposing of used absorbent articles, according to one embodiment.

FIG. 3 illustrates an isometric, partially cutaway view of a lidded,stacked and angled container for dispensing unused absorbent articlesand for visibly disposing of used absorbent articles, according to oneembodiment.

FIG. 4 illustrates a side view in vertical cross section of the lidded,stacked and angled container of FIG. 3, according to one embodiment.

FIG. 5 illustrates an isometric, partially cutaway view of the lidded,stacked and angled container of FIG. 3 with a top lid stowed underneathas an antiskid surface, according to one embodiment.

FIG. 6 illustrates a side view in vertical cross section of the angledcontainer of FIG. 5 with the lid stowed, according to one embodiment.

FIG. 7 illustrates a side view in vertical cross section of an alternatelidded, stacked and horizontal container, according to one embodiment.

FIG. 8 illustrates a diagram of a 3×3 arrangement of a stackedcontainer, according to one embodiment.

FIG. 9 illustrates a diagram of a 2×5 arrangement of a stackedcontainer, according to one embodiment.

DETAILED DESCRIPTION

The present invention involves the use of materials and methods forsurgical sponges and related medical devices, which will be used toidentify and track those sponges during surgery.

The sponge count is an essential part of operating room procedure. Thepresent invention will increase the accuracy of sponge counts byeliminating human error and providing a running count of sponges alreadyused. This is important because it allows the staff to constantly checkcounts throughout the procedure. An increase in accuracy reduces thechances that a sponge will be left in a patient. This increases safetyfor the patient and reduces the time that is spent recounting sponges,thus reducing total count time.

The present innovation relates generally to a surgical container thathas more than one surgical sponge, more than one dispensing containerscontaining respectively the more than one surgical sponge, and more thanone disposal containers each proximate to and visually associatedrespectively with the more than one dispensing containers to receive aused surgical sponge, wherein a selected surgical sponge is visible inone of the dispensing container or the corresponding disposal container.

Detailed descriptions of well-known sponge material, methods ofattaching or incorporating a marker, manufacturing methods, and methodsof packaging are omitted so as not to obscure the description of thepresent invention. In addition, as will be evident to those skilled inthe art, the present invention could be used in place of, or inconjunction with, the currently available surgical pads and sponges,including laparotomy pads.

In one embodiment, the sponge management system of the present inventionprovides for individual sponges to be segmented into compartments likean egg carton. However, the carton has a double chamber—a second onebelow or adjacent to the first—wherein there is a keyhole between thetwo compartments. After use, the used sponge is pushed through thekeyhole (or v-shaped) into deeper chamber. The used sponge may be hookedinto keyhole slot to hang over side and remain visible. The sponges maybe labeled with a color-coordinated segment and number so that the countis easily verified. In one embodiment, each pack is a specific colorsuch that one pack is one color e.g., red #1, red #2, red #3, etc., andanother pack is another color such as blue #1, blue #2, blue #3, etc. Inone embodiment, a system is provided such that a variety of surgicalsponge packs are provided wherein each pack has a unique color coding sothat as the labeled sponges are disposed of, only the coordinating colorsponges are placed in the pack compartments.

In one embodiment, the disposal compartment of the container is sizedappropriately such that the volume of the disposal compartment is largeenough to contain only a single sponge so that two sponges cannotinadvertently be placed into a single, disposal compartment.

In one embodiment, individual sponges are segmented into compartmentslike an egg carton. However, the carton has a double chamber—a secondone in front of the first—wherein there is a keyhole slot opening to thesecond compartment adjacent for immediate disposal after use. After use,the used sponge is pushed through the keyhole (or v-shaped) into secondcompartment but the used sponge is hooked into keyhole slot to hang overside and remain visible.

In one embodiment, the sponges are labeled with a color-coordinatedsegment and number so that the count is easily verified. In oneembodiment, each pack is a specific color e.g., red 1, red 2, etc., blue1, blue 2, etc. or red A, red B, etc. In another embodiment, differentcolors are used to indicate different types of sponges. The ability todistinguish between different types of sponges helps to accuratelyestimate the amount of blood lost during surgery. For example, Raytecsponges weigh, when dry, about five grams. Lap sponges weigh, when dry,about 20 grams. When soaked with blood and/or other bodily fluids,Raytec sponges can weigh up to about 50 grams and Lap sponges can weighup to about 120 grams.

Turning to the drawings, wherein like numerals represent like componentsthroughout the several view, FIG. 1 illustrates a first examplecontainer 100 for dispensing unused absorbent articles 102 such assurgical sponges, gauzes, towels, etc., and for visibly disposing ofused absorbent articles 102′, according to one embodiment. For clarity,one rows of four dispensing container 104 a-104 d are depicted, althoughmore rows, rows of different numbers or letters, and orientations otherthan straight may be used consistent with aspects of the presentdisclosure. To assist in tracking, each unused absorbent article 102that may eventually become a used absorbent article 102′ is labeled witha sequential indicium 106 (e.g., number, alphabet letter, color, etc.)that assists in disposing of the then used absorbent article 102 in avisually associated and corresponding disposal container 108 a-108 dthat is proximate respectively to the dispensing container 104 a-104 s.Apertures 110 a-110 d respectively in the disposal containers 108 a-108d may be a slit, teardrop, or other shape that may grip for exposure ofthe sequential indicium 106 for tracking purposes.

FIG. 2 illustrates a second example container 200 for dispensing unusedabsorbent articles 102 and for visibly disposing of used absorbentarticles 102′ wherein each dispenser container 204 is positioned abovethe corresponding disposal container 208.

FIGS. 3-6 illustrate a lidded, stacked and angled surgical container 300for dispensing unused absorbent articles 102 and for visibly disposingof used absorbent articles 102′. The surgical container 300 has morethan one dispenser containers 304 are inclined toward an orientation ofa user and are above corresponding disposal containers 308. Thecontainer 100 may comprise transparent material to expose contents ofeach disposal container 308. A transparent sterile membrane 312 encloseseach dispensing container 304. A lid 314 is sized to enclose the morethan one dispensing container 304 and to be received on a bottom 316 ofthe surgical container 300 until needed to close the container 300 afteruse or to provide a slip resistant surface.

FIG. 7 illustrates an alternate lidded, stacked and horizontal container400 having horizontal dispensing containers 404 overtop of correspondingdisposal containers 408 for managing unused and used absorbent articles102, 102′.

FIG. 8 illustrates a portion of a 3×3 stacked container 500 of trays501, according to one embodiment.

FIG. 9 illustrates a portion of a 2×5 stacked container 600 of trays601, according to one embodiment.

An absorbent article 102 such as a surgical sponge is provided andadapted to prevent unaccounted disposal thereof. The sponge includes anabsorbent pad and a visually identifiable member attached to the pad.The visually identifiable member assists in identification andaccounting in a surgical environment. In another embodiment, anadditional a tag of sufficient size is incorporated with the sponge toprovide detection by a metal detector device upon disposal of thesponge.

Referring now to FIG. 2, an absorbent article 102 is illustrated andincludes an absorbent pad that is labeled with a sequential indicium 106(e.g., number, alphabet letter, color, etc.). The sequential indicium106 may be attached to the absorbent article 102 in any manner thatmakes the sequential indicium 106 visually identifiable.

In one embodiment, the absorbent article 102 is color-coded in a colorcontrasting with the colors typically found in a body cavity of apatient. Such colors may include blue, yellow, orange, lavender, greenand the like. This provides two primary benefits. First, when theabsorbent article 102 is placed within the body cavity of a patient, forexample, so that the absorbent article 102 becomes absorbed in blood andother bodily fluids, the color of the absorbent article 102 and/orsequential indicium 106 can still be readily seen since it is contrastedwith the fluid and tissue colors of the patient. Moreover, the colorsutilized with the absorbent article 102 and/or sequential indicium 106may also be color matched or coordinated to the box container or otherholder to permit easy counting to determine the absence of any absorbentarticle 102 after the surgery is complete.

In other embodiments, the material of the absorbent article 102 itselfis color-coded in a color. In other embodiments, the sequential indicium106 of the absorbent article 102 is color-coded in a color. In otherembodiments, both the absorbent article 102 itself and the sequentialindicium 106 of the absorbent article 102 are color-coded in a color.

However, mere color coding of tagged or other identifying elementsassociated with the absorbent article 102 by itself may still beinsufficient. This is due to the fact that while the color contrast maymake the sponges easier to identify within the body cavity of a patient,the proper number of sponges must be counted in order to indicate a lackof accounting of all the sponges. To obviate the above problem withoutusing expensive active sensors, the absorbent article 102 of the presentinvention optionally includes a number tag as part of the sequentialindicium 106 associated with the visually identifiable absorbent article102.

In one embodiment, the sponge is made of an absorbent material andfurther comprises a radio-opaque material, wherein the radio-opaquematerial is incorporated into the absorbent material.

The absorbent article 102 can be of any desired thickness, and in oneembodiment is in the range of about 1 to about 5 millimeters inthickness, which is sufficient for fluid absorption, possesses adequatepermeability for use with fluid suction devices, and is sufficientlypliable to serve as a tissue wipe.

In one embodiment, the sponge has the material enhancing the adherenceof the sponge to the applied tissue in the form of a continuous ordiscontinuous layer on at least one surface of the sponge.

In one embodiment, the sponge of the present invention has an overallthickness of less than 5 mm. In another embodiment, the sponge has anoverall thickness of less than 3 mm. In another embodiment, the spongehas an overall thickness of about 1 mm to about 3 mm.

The sponge may further comprise an activator or proactivator of bloodcoagulation, including fibrinogen, thrombin or a thrombin precursor, ase.g. disclosed in U.S. Pat. No. 5,714,370 (incorporated herein byreference). In the following thrombin activity is understood to compriseboth, the activity of thrombin or any equivalent activity. A proteinwith thrombin activity might be selected from the group consisting ofalpha-thrombin, meizothrombin, a thrombin derivative or a recombinantthrombin. A suitable precursor is possibly selected from the groupconsisting of: prothrombin, factor Xa optionally together withphospholipids, factor IXa, activated prothrombin complex, FEIBA, anyactivator or a proactivator of the intrinsic or extrinsic coagulation,or mixtures thereof

The sponge according to the invention can optionally be used togetherwith further physiologic substances. For example, the sponge optionallyfurther comprises pharmacologically active substances, among themantifibrinolytics, such as a plasminogenactivator-inhibitor or a plasmininhibitor or an inactivator of fibrinolytics. A preferredantifibrinolytic is selected from the group consisting of aprotinin oran aprotinin derivative, alpha2-macroglobulin, an inhibitor orinactivator of protein C or activated protein C, a substrate mimicbinding to plasmin that acts competitively with natural substrates, andan antibody inhibiting fibrinolytic activity.

In one embodiment, the further pharmacologically active substance is anantibiotic, such as an antibacterial or antimycotic. Further bioactivesubstances such as growth factors and/or pain killers may be alsopresent in the inventive sponge. Such a sponge might be useful in e.g.wound healing.

Further combinations are useful with specific enzymes or enzymeinhibitors, which may regulate, i.e. accelerate or inhibit, theresorption of the sponge. Among those are collagenase, its enhancers orinhibitors. Also, a suitable preservative may be used together with thesponge or may be contained in the sponge.

In one embodiment, the absorbent article 102 is constructed from anabsorbent material (cotton) comprising a plurality of layers of openmesh gauze. As is well-known in the art, the gauze is preferably wovenin a weave pattern suitable for use both as a drape in a surgicalprocedure and in the nature of a laparotomy sponge. Alternately, theabsorbent article 102 could be constructed of a nonwoven material. Thenonwoven fabric may comprise any suitable combination of natural and/orsynthetic textile materials including cotton, rayon, acrylics, polyesterand nylon.

A surgical sponge in accordance with the present invention may befabricated by weaving polymer filaments into a sheet and cuttingappropriately dimensioned pledgets therefrom. The sponge, though shownin the shape of a sheet pad, may be formed in any desired and sensibleshape.

In another embodiment, the sponge is comprised of a bioabsorbablematerial formed into a body having a plurality of interconnecting poresthat open to the surface of the sponge. The bioabsorbable material maybe a fibrous mass of bioabsorbable filaments or it may be abioabsorbable “open cell” foam body. The biodegradable material used forthe construction of the sponge should preferably have a hydrophilicouter surface to facilitate the absorbtion of blood into the sponge.Suitable biodegradable materials for fabricating the surgical spongeinclude filaments or foam bodies comprised of polymers or copolymers oflactide, glycolide, caprolactone, polydioxanone, trimethylene carbonate,polyorthoesters and polyethylene oxide, collagen and high molecularweight polysaccharides from connective tissue such as chondroitin salts.Other polysaccharides that can be formed into a porous body may alsoprove suitable, such as chitin and chitosan. Additional bioabsorbablematerials are in intense development and it is expected that many of thenew materials will also be applicable for forming a biodegradablesurgical sponge in accordance with the present invention.

The sponges of the present invention may be sterilized by heat, ethyleneoxide or radiation, the choice depending on the sponge materialselected.

In a still further embodiment of the invention, the sponge is providedin combination with a high radiographic density and a high effectivearea for an x-ray beam incident thereon at any orientation.

In a still further embodiment of the invention, the sponge container ismarked in an area on the outer surface. In one embodiment, the spongecontainer may be marked in an area on the outer surface with a beforeand after weight that enables a person to weigh the container to see theadditional weight added after the sponges are used to compare with theoriginal dry sponges, in single or stacked containers, to obtain a moreaccurate estimate of blood loss during surgery. Alternatively, thecontainer comprises a transparent material to permit a doctor tovisually inspect the blood-soaked sponges confined in their containersto assess the blood loss.

In a still further embodiment of the invention, the main part of thesponge container s a single compartment formed from a transparent,semi-rigid, thermoplastic material on a packaging machine to hold cleansurgical sponges.

In a further aspect of the invention, the surgical sponge comprises incombination a radiographic marker and a remotely detectable electronicarticle surveillance tag. Such a sponge advantageously may be detectedby the electronic means and removed from the patient prior to completionof surgery. However, even if the sponge is inadvertently not detectedand removed, the marker further enhances the detectability of thepresent sponge in comparison to sponges bearing previously knownradiopaque elements.

In a further aspect of the invention, the surgical sponge provides aradiopaque marker suitable for association with a surgical sponge orother surgical implement. The marker has a high radiographic density anda distinctive shape, whereby the marker produces an x-ray image withhigh contrast and a shape that is readily recognizable anddifferentiated from the images produced by other items and structurescommonly seen in x-rays of post-operative patients. The marker issuitable for association with a surgical sponge and has an x-ray densityequivalent to at least about 0.1 g/cm2 of BaSO₄.

The marked surgical sponge of the invention may be used in conjunctionwith any remotely detectable electronic article surveillance (EAS) tagsystem capable of sensing and remotely detecting an EAS tag andcompatible with the requirements of safe operation in the context of amedical venue. A wide variety of such EAS systems are currently known,including microwave, RF, and magnetic systems. Some of these systemsemploy substantially identical tags, so that the system simply indicatesthe presence or absence of a tag. Other systems have now becomeavailable in which each tag has a unique signature that is remotelyrecognizable by the detection system. One such system is themagneto-mechanically actuated article surveillance system disclosed byU.S. Pat. Nos. 4,510,489 and 4,510,490. Another system is theharmonic-responsive article surveillance system disclosed by US PatentRE 35,042.

Many tags suitable for use in the practice of the present inventioncomprise an active electronic receptor element that is encased in aplastic housing comprising some means allowing the tag to be attached toanother item. The term “tag” is used herein to refer generically to thecombination of the active element and any housing or related mountingmeans. In addition, it will be understood that a tag may include morethan one active element, which elements may be responsive to EAS systemsof different types. It will also be appreciated that more than one tagmay be attached to a given surgical item to further improve itsdetectability or to allow detection by EAS systems of different types.In one embodiment, the tags can endure temperatures of up to about 400degrees Fahrenheit (about 200 degrees Centigrade) to allow them to beautoclaved.

It must be noted that, as used in this specification and the appendedclaims, the singular forms “a,” “an” and “the” include plural referentsunless the content clearly dictates otherwise. Thus, for example,reference to a “colorant agent” includes two or more such agents.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which the invention pertains. Although a number of methodsand materials similar or equivalent to those described herein can beused in the practice of the present invention, the preferred materialsand methods are described herein.

As will be appreciated by one having ordinary skill in the art, themethods and compositions of the invention substantially reduce oreliminate the disadvantages and drawbacks associated with prior artmethods and compositions.

It should be noted that, when employed in the present disclosure, theterms “comprises,” “comprising,” and other derivatives from the rootterm “comprise” are intended to be open-ended terms that specify thepresence of any stated features, elements, integers, steps, orcomponents, and are not intended to preclude the presence or addition ofone or more other features, elements, integers, steps, components, orgroups thereof.

As required, detailed embodiments of the present invention are disclosedherein; however, it is to be understood that the disclosed embodimentsare merely exemplary of the invention, which may be embodied in variousforms. Therefore, specific structural and functional details disclosedherein are not to be interpreted as limiting, but merely as a basis forthe claims and as a representative basis for teaching one skilled in theart to variously employ the present invention in virtually anyappropriately detailed structure.

While it is apparent that the illustrative embodiments of the inventionherein disclosed fulfill the objectives stated above, it will beappreciated that numerous modifications and other embodiments may bedevised by one of ordinary skill in the art. Accordingly, it will beunderstood that the appended claims are intended to cover all suchmodifications and embodiments, which come within the spirit and scope ofthe present invention.

What is claimed is:
 1. A surgical container, comprising: more than onesurgical sponge; more than one dispensing containers containingrespectively the more than one surgical sponge; and more than onedisposal containers each proximate to and visually associatedrespectively with the more than one dispensing containers to receive aused surgical sponge, wherein a selected surgical sponge is visible inone of the dispensing container or the corresponding disposal container.2. The surgical container of claim 1, wherein each dispenser containeris positioned above the corresponding disposal container.
 3. Thesurgical container of claim 2, wherein more than one dispensercontainers are inclined toward an orientation of a user.
 4. The surgicalcontainer of claim 1, wherein each dispensing container is positionedadjacent to the corresponding disposal container.
 5. The surgicalcontainer of claim 1, wherein the disposal container comprises anaperture to grip and expose a portion of a received used surgicalsponge.
 6. The surgical container of claim 5, wherein the more than onedispensing container comprise a row of trays and the more than onedisposal containers comprises a downward angled top that is orientedtoward a user.
 7. The surgical container of claim 1, further comprisinga transparent material to expose contents of each disposal container. 8.The surgical container of claim 1, further comprising: a transparentsterile membrane that encloses each dispensing container; and a lidsized to enclose the more than one dispensing container and to bereceived on a bottom of the surgical container.
 9. A surgical itemoperable for the intraoperative absorption of blood from within an opensurgical site within a patient, wherein the surgical item comprises asponge having a porous body and a marker integrated within the sponge,wherein the marker comprises an identifiable number and an identifiablecolor; wherein the marker is capable of functioning after enduringfluids, including blood and other bodily fluids.
 10. The surgical itemof claim 9 wherein the sponge is a laparotomy sponge.
 11. The surgicalitem of claim 9 wherein the sponge includes a radio-opaque member. 12.The surgical item of claim 9 wherein the sponge comprises abioabsorbable material.
 13. The surgical item of claim 9 wherein thesponge has a thickness of about 1 to about 5 millimeters and issufficient for fluid absorption.
 14. The surgical item of claim 9wherein the sponge further comprises material for enhancing theadherence of the sponge to human tissue in the form of a continuous ordiscontinuous layer on at least one surface of the sponge.
 15. Thesurgical item of claim 9 wherein the sponge further comprises anactivator or proactivator of blood coagulation.
 16. The surgical item ofclaim 9 wherein the sponge further comprises a pharmacologically activesubstance.
 17. The surgical item of claim 9 wherein the sponge furthercomprises a second marker.
 18. The surgical item of claim 17 wherein thesecond marker is a second identifiable color.
 19. The surgical item ofclaim 17 wherein the second marker is a remotely detectable electronicarticle surveillance (EAS) tag system